Key Challenges for In Vitro Testing of Tobacco Products for Regulatory Applications: Recommendations for the In Vitro Mouse Lymphoma Assay

• Published in: Alternatives to laboratory animals Vol. 52; no. 1; pp. 42 - 59
• Main Authors: Crooks, Ian, Clements, Julie, Curren, Rodger, Guo, Xiaoqing, Hollings, Michael, Lloyd, Mel, Smart, Daniel, Thorne, David, Weber, Elisabeth, Moore, Martha
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-01-2024
• Subjects: genotoxicity; heated tobacco products; tobacco products; electronic nicotine delivery systems; mouse lymphoma assay; mutagenesis
• ISSN: 0261-1929; 2632-3559
• DOI: 10.1177/02611929231219153

The Institute for In Vitro Sciences (IIVS) is sponsoring a series of workshops to develop recommendations for optimal scientific and technical approaches for conducting in vitro assays to assess potential toxicity within and across traditional tobacco and various tobacco and nicotine next-generation products (NGPs), including Heated Tobacco Products (HTPs) and Electronic Nicotine Delivery Systems (ENDS). This report was developed by a working group composed of attendees of the seventh IIVS workshop, ‘Approaches and recommendations for conducting the mouse lymphoma gene mutation assay (MLA) and introduction to in vitro disease models’, which was held virtually on 21–23 June 2022. This publication provides a background overview of the MLA, and includes the description of assay conduct and data interpretation, key challenges and recommended best practices for evaluating tobacco and nicotine products, with a focus on the evaluation of NGPs, and a summary of how the assay has been used to evaluate and compare tobacco and nicotine products.